NIACIN - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for niacin and what is the scope of freedom to operate?
Niacin
is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Abbvie, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for niacin. Eleven suppliers are listed for this compound.
Summary for NIACIN
US Patents: | 0 |
Tradenames: | 7 |
Applicants: | 28 |
NDAs: | 35 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 211 |
Clinical Trials: | 171 |
Patent Applications: | 7,089 |
Drug Prices: | Drug price trends for NIACIN |
Drug Sales Revenues: | Drug sales revenues for NIACIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NIACIN |
What excipients (inactive ingredients) are in NIACIN? | NIACIN excipients list |
DailyMed Link: | NIACIN at DailyMed |
Recent Clinical Trials for NIACIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Centre de recherche du Centre hospitalier universitaire de Sherbrooke | N/A |
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | N/A |
Rhode Island Hospital | Early Phase 1 |
Pharmacology for NIACIN
Drug Class | Nicotinic Acid |
Medical Subject Heading (MeSH) Categories for NIACIN
US Patents and Regulatory Information for NIACIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Beijing | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 214428-002 | Nov 22, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Purepac Pharm | NIACIN | niacin | TABLET;ORAL | 083271-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-003 | Jul 28, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | NIACIN | niacin | TABLET;ORAL | 083306-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 200484-002 | Apr 23, 2014 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 203742-002 | Feb 22, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rising | NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 203742-001 | Feb 22, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NIACIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-002 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-001 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN TITRATION STARTER PACK | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-005 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-001 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-004 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-003 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NIASPAN | niacin | TABLET, EXTENDED RELEASE;ORAL | 020381-002 | Jul 28, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.